CxBladder Surveillance of Intermediate and High-Risk Bladder Cancer Patients

Description

Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective single arm multi-center study using the diagnostic CxBladder test with subjects previously diagnosed positive with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of urothelial carcinoma presenting to qualified sites. To test the pathway multiple consecutive urine samples will be collected during the course of surveillance and records review follow-up will also be completed.

Conditions

Urothelial Bladder Cancer

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Study Overview

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Study Details

Study overview

Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective single arm multi-center study using the diagnostic CxBladder test with subjects previously diagnosed positive with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of urothelial carcinoma presenting to qualified sites. To test the pathway multiple consecutive urine samples will be collected during the course of surveillance and records review follow-up will also be completed.

An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Intermediate and High-Risk Patients

CxBladder Surveillance of Intermediate and High-Risk Bladder Cancer Patients

Condition
Urothelial Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

White River Junction

White River Junction Veterans Affair Medical Center, White River Junction, Vermont, United States, 05009

Seattle

University of Washington School of Medicine, Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. High and intermediate risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma
  • 2. Subjects must agree to 4 successive visits including urine sample collection at each of the study visits and records review follow-up
  • 3. Able to provide a voided urine sample (a sample from catheterization is not eligible) of the required minimum volume
  • 4. Able to give written consent
  • 5. Able and willing to comply with study requirements
  • 6. Aged 18 years or older
  • 1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterization, urethral dilation) in the 14 days before urine collection
  • 2. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
  • 3. Previous muscle invasive bladder tumour (pT2 or greater)
  • 4. Pregnancy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pacific Edge Limited,

Tony Lough, STUDY_CHAIR, Pacific Edge Pty Ltd

Study Record Dates

2025-12-31